WL-AAD-Z-W-1371 (MASTER ALLEYOOP)- zinc oxide lotion
Nanophase Technologies Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

WL-AAD-Z-W-1371 (Master Alleyoop)

GHS Label

WL-AAD-Z-W-1371 (MASTER ALLEYOOP)
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63931-4520
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	132 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
JOJOBA OIL (UNII: 724GKU717M)
ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TOCOPHEROL (UNII: R0ZB2556P8)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
COCO-CAPRYLATE (UNII: 4828G836N6)
NYLON-12 (UNII: 446U8J075B)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
METHYLHEPTYL ISOSTEARATE (UNII: 981F40Q9FF)
ALLANTOIN (UNII: 344S277G0Z)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ROSMARINUS OFFICINALIS FLOWER (UNII: NR1A27F29O)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
NIACINAMIDE (UNII: 25X51I8RD4)
PROPANEDIOL (UNII: 5965N8W85T)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63931-4520-1	150000 mL in 1 DRUM; Type 0: Not a Combination Product	12/05/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	12/05/2022

Labeler - Nanophase Technologies Corporation (623502044)

Registrant - Nanophase Technologies Corporation (623502044)

Name	Address	ID/FEI	Business Operations
Establishment
Nanophase Technologies Corporation		050383046	api manufacture(63931-4520)

Name	Address	ID/FEI	Business Operations
Establishment
Nanophase Technologies Corporation		623502044	api manufacture(63931-4520) , manufacture(63931-4520) , pack(63931-4520)

Revised: 2/2023

Document Id: f4abf64d-5042-3182-e053-2a95a90ae2ae

Set id: f4abf64d-5041-3182-e053-2a95a90ae2ae

Version: 1

Effective Time: 20230214

Nanophase Technologies Corporation